Food and Drug Administration, Dockets Management Branch, 5630 Fishers Lane - Room 1061- HFA-305, Rockville, MD, 20852; 301-827-6860; Fax 301-827-6870 [E-mail Us]

DOCKETS ENTERED on January 28, 2002

TABLE OF CONTENTS

Hyper links are part of the Docket  title - not all dockets/documents are linked

NOTE:  Documents received by the Dockets Management Branch "MAY" be posted on the Internet.

PLEASE DO NOT  include personal identifying information, i.e. date of birth, social security number, etc., in your correspondence.

[FDA DOCKETS PAGE] [FDA HOME PAGE]  [ ITEM CODES ]

 
94S-0120 510K Substantially Equivalent List *
95P-0273 Waiver for Feminine Gold external topical analgesic lotion *
99P-5198 Request amendment of the definition of milk *
00P-0586 Amend Pt 133.3 re:Milk and Nonfat Milk for use in Standardiz *
01D-0488 Food-Effect Bioavailability & Fed Bioequivalence Studies *
01D-0501 Management of Periodic Summary Update Reports *
01P-0585 Requirement of ANDA for Mixed Salts of Single Entity Amphet *
01P-0586 New and/or Amended Regulations for BPCA *

77N-0085 Saccharin and Its Salts

C 33926 Jan C. Fox Vol#: 570

C 33927 Alma M. Otto Vol#: 570

CA 33618 Judy Tedder Vol#: 567

CA 33619 Naomi Nadel Vol#: 567

CA 33620 Mr. Jesse Raphael Vol#: 567

CA 33621 Marjorie Neff Vol#: 567

CA 33622 Kenneth & Pearl Lord Vol#: 567

CA 33623 Mrs. Floyd Hall Vol#: 567

CA 33624 Elizabeth Weinberger Vol#: 567

CA 33625 Stanley Suk Vol#: 567

CA 33626 Mrs. Quentin T. Rubin Vol#: 567

CA 33627 Mr. & Mrs. Allen F. Sokolsky Vol#: 567

CA 33628 Mr. Remo C. & Mrs. Mary Lou Chiurato Vol#: 567

CA 33629 Classen Gramm Vol#: 567

CA 33630 Ernest I. Baker Vol#: 567

CA 33631 Mr. & Mrs. Steve Slenn Vol#: 567

CA 33632 Mary Underwood Vol#: 567

CA 33633 Mrs. Henry M. O'Neill Vol#: 567

CA 33634 Suzanne Lewis Vol#: 567

CA 33635 David N. Bateman Ph.D. Vol#: 567

CA 33636 Vol#: 567

CA 33637 Marilyn Preuss Vol#: 567

CA 33638 Mrs. Charles Patterson Vol#: 567

CA 33639 B. Cohen Vol#: 567

CA 33640 Ralph W. Wilkening Vol#: 567

CA 33641 Helene Miller Vol#: 567

CA 33642 Mary H. Thomsen Vol#: 567

CA 33643 Mrs. Larraine Isola Vol#: 567

CA 33644 Alexander Marble Vol#: 567

CA 33645 Thomas A. Mayton Vol#: 567

CA 33646 Mrs. John W. Butterworth Vol#: 567

CA 33647 Christine C. Orlando Vol#: 567

CA 33897 Judy Fuchs Vol#: 570

CA 33898 Lesley D. Gray Vol#: 570

CA 33899 Agnes H. Ulmer Vol#: 570

CA 33900 Kathleen M. Thomas Vol#: 570

CA 33901 Howard O. Allen Vol#: 570

CA 33902 Mrs. C. Postema Vol#: 570

CA 33903 Jack Kronert Vol#: 570

CA 33904 Earlene J. Russell Vol#: 570

CA 33905 Carol J. Jenkins Vol#: 570

CA 33906 Mrs. Richard Novy Vol#: 570

CA 33907 Jean L. Gilbert Vol#: 570

CA 33908 John Stevenson Vol#: 570

CA 33909 Mr. & Mrs. Harlan Walters Vol#: 570

CA 33910 Mrs. George H. Cash Vol#: 570

CA 33911 Marilyn R. Schnabl Vol#: 570

CA 33912 Patricia C. Matlack Vol#: 570

CA 33913 Gloria Loudon Vol#: 570

CA 33914 SP4 Christopher G. Weber Vol#: 570

CA 33915 Harriett Lindquist Vol#: 570

CA 33916 Julia C. Doles Vol#: 570

CA 33917 Gloria M. Grimm + 38 signatures Vol#: 570

CA 33918 David S. Yaney Vol#: 570

CA 33919 Joan Coughlan Vol#: 570

CA 33920 Mary Hunt Vol#: 570

CA 33921 S.M. 'Al' Alexander Vol#: 570

CA 33922 Sheila H. Pore Vol#: 570

CA 33923 Jeannine Hodges Vol#: 570

CA 33924 Patricia Weber Vol#: 570

CA 33925 Colile M. Holland Vol#: 570

CA 33928 Terri A. Reichenbacher Vol#: 570

CA 33929 Margaret Lawrie Vol#: 570

CA 33930 Ida Gummerson Vol#: 570

CA 33931 Julie Gott Vol#: 570

CA 33932 Patricia Eguia Vol#: 570

CA 33933 Charles G. Steinway Vol#: 570

CA 33935 Marilyn Morehouse Vol#: 570

CA 33936 Patricia A. Muehlberg Vol#: 570

CA 33937 C. L. Nicely Vol#: 570

CA 33938 Mary Ann Bundshick Vol#: 570

CA 33939 Anne & Virginia Swatfigure Vol#: 570

CA 33940 Jackie Hofhenke Vol#: 570

CA 33941 Kay Krochman Vol#: 570

CA 33942 Edward Bradfield Vol#: 570

CA 33944 Frank R. Jones Vol#: 570

CA 33945 K. Don Levy Vol#: 570

CA 33946 Virginia Cunningham Vol#: 570

CA 33947 George H. Cherrington, Jr. Vol#: 570

CA 33948 John & Brenda Dixon Vol#: 570

CA 33949 Rita Moskin Vol#: 570

CA 33950 Terry Fecik Vol#: 570

CA 33951 Herbert Doeltz Vol#: 570

CA 33952 Patricia A. Koczan Vol#: 570

CA 33953 Marie Daniels Vol#: 570

CA 33954 Fred C. Allen Vol#: 570

CA 33955 Leta D. Barlos Vol#: 570

CA 33956 Audrey Moon Vol#: 570

CA 33957 Mrs. Gordon Dillow Vol#: 570

CA 33958 Blanche Peep Vol#: 570

CA 33959 Lin Sullivan Vol#: 570

CA 33960 Beverly Steckley Vol#: 570

CA 33961 C. Coon Vol#: 570

CA 33962 Christine Vinn Vol#:

CA 33963 Catherine E. Hunt Vol#: 571

CA 33964 Mrs. Patricia Wadple Vol#: 571

CA 33965 Mr. & Mrs. Theadore C. Touchette Vol#: 571

CA 33966 Mrs. Collins B. Reed Vol#: 571

CA 33967 Margaret E. Benson Vol#: 571

CA 33968 Marilyn R. Vaupel Vol#: 571

CA 33969 Rev. Frank P. Sullivan Vol#: 571

CA 33970 Mildred Anderson & 70 other signatures Vol#: 571

CA 33971 William Emil Kaser Vol#: 571

CA 33972 Mrs. B. J. Roife Vol#: 571

CA 33973 Mrs. Dan Wilkerson Vol#: 571

CA 33974 Marion H. Horn Vol#: 571

CA 33975 Mrs. Richard Wertz Vol#: 571

CA 33976 Flori A. Gough Vol#: 571

CA 33977 Mrs. Alice H. Manning Vol#: 571

CA 33978 George H. Bailey Vol#: 571

CA 33979 Beatrice B. Hodges Vol#: 571

CA 33980 Marie R. Gartland Vol#: 571

CA 33981 Richard A. Hatch Vol#: 571

CA 33982 Hazel M. Wehmer Vol#: 571

CA 33983 Mrs. M. McWilliams Vol#: 571

CA 33984 Kathryn T. Bradley Vol#: 571

CA 33986 Jim D. Meehan Vol#: 571

CA 33987 John B. Rucker Vol#: 571

CA 33988 George E. Johnson Vol#: 571

CA 33989 Bernard Landers, C. L. U. Vol#: 571

CA 33990 Patricia A. Breyley Vol#: 571

CA 33991 Miss. D. M. Grant Vol#: 571

CA 33992 Joe Goode Vol#: 571

CA 33993 Helen Batschelet Vol#: 571

CA 33994 Becky Cortner Vol#: 571

CA 33995 Clarke Schumacker Vol#: 571

CA 33996 Betty J. Starns Vol#: 571

CA 33997 Marjorie Hungate Vol#: 571

CA 33998 Robert C. Nichols, Jr. Vol#: 571

CA 33999 Jack M. Linton Vol#: 571

CA 34000 W. H. Krommes & Bill Makemson Vol#: 571

CA 34001 Evelyn M. Madden Vol#: 571

CA 34002 LaRonda Smith & 30 other signatures Vol#: 571

CA 34003 Martha R. Woodward Vol#: 571

CA 34004 Maurice B. Cossman Vol#: 571

CA 34006 Mrs. Charles M. Ringsmith Vol#: 571

CA 34007 Ida M. Windham Vol#: 571

CA 34008 D. V. Scanzaroli Vol#: 571

CA 34009 Edward P. Sevcik Vol#: 571

CA 34011 J. E. O'Conn Vol#: 571

CA 34012 Mrs. George A. Brackett Vol#: 571

CA 34013 Lucille P. Schnebly Vol#: 571

CA 34014 Alma L. Arent Vol#: 571

CA 34015 Dorothy M. Richardson Vol#: 571

CA 34016 Ruth A. D'errico Vol#: 571

CA 34017 Francine Mallozzi Vol#: 571

CA 34018 Carol Perkins Vol#: 571

CA 34019 Walter E. Davies Vol#: 571

CA 34020 Mrs. Robert B. Erckman Vol#: 571

CA 34021 Mrs. Harold Blue, Sr. Vol#: 571

CA 34022 Candace M. Richson Vol#: 571

CA 34023 Mrs. Kathleen Schofield Vol#: 571

CA 34024 Mrs. L. M. Della-Bitta Vol#: 571

CA 34025 Albert Robins Vol#: 571

CA 34026 Mrs. Leonard Leff Vol#: 571

CA 34027 Marelyn Baker Vol#: 571

CA 34028 Mrs. Martha Scott Vol#: 571

CA 34029 Warren C. Smith Vol#: 571

CA 34030 Rita Tesler Vol#: 571

CA 34031 Mrs. Annette Ehrhardt Vol#: 571

CA 34032 Mrs. Donald R. Holt Vol#: 571

CA 34033 B. W. & Joanna Harless Vol#: 571

CA 34034 Nancy Volding Vol#: 571

CA 34035 Edward D. Hesseman Vol#: 571

CA 34036 John H. Silg Vol#: 571

CA 34037 Genia Silverberg Vol#: 571

CA 34038 Gail Schlachter Vol#: 571

CA 34039 Herald W. Gibson Vol#: 571

CA 34040 Mrs. Hilda Allen Vol#: 571

CA 34041 Wilford E. Pierce Vol#: 571

CA 34042 Ben Tobman Vol#: 571

CA 34043 Shirley J. Krieko Vol#: 571

CA 34044 Mrs. R. C. Fisher Vol#: 571

CA 34046 Norman E. Eldridge Vol#: 571

CA 34047 E. L. Dunn Vol#: 571

CA 34048 Betty Bator Vol#: 571

CA 34049 Anne Marie Moss Vol#: 571

CA 34050 Mrs. Sam Martino Vol#: 571

CA 34051 Mr. & Mrs. Joe Stocks Vol#: 571

CA 34052 Joan Cummings Vol#: 571

CA 34053 Mrs. Adele Badish Vol#: 571

CA 34054 Mrs. Gus L. Barry, Jr. Vol#: 571

CA 34055 Carolyn A. Kresen Vol#: 571

CA 34056 Alice Meaders Vol#: 571

CA 34057 Mrs. Olive L. Searcy Vol#: 571

CA 34058 Suzette L. Binder Vol#: 571

CA 34059 Vivian H. Schmidt Vol#: 571

CA 34060 Judith M. Ando Vol#: 571

CA 34061 Carol Schmidt Vol#: 571

CA 34062 Bernard Ferch Vol#: 571

CA 34114 W. S. Myerss Vol#: 572

CA 34116 Charles Ponter Vol#: 572

CA 34117 Dr. P. B. Alexander Vol#: 572

CA 34118 Edna Soares Vol#: 572

CA 34119 Mrs. Balsan Vol#: 572

CA 34120 Wilma Buechek Vol#: 572

CA 34121 Mrs David Booth Vol#: 572

CA 34122 Esther L. Strong Vol#: 572

CA 34123 Gary Bart Vol#: 572

CA 34124 Mr. & Mrs. James M. Bradley Vol#: 572

CA 34125 Rosemary Mannino Vol#: 572

CA 34126 Mr. & Mrs. Myron A. Brown Vol#: 572

CA 34127 Mrs. Paul T. Acey Vol#: 572

CA 34128 Mrs. Helen Demarest Vol#: 572

CA 34129 Mrs. Ernest Doxsey Vol#: 572

CA 34130 Mr. & Mrs. John Basham Vol#: 572

CA 34131 Edward H. Concannon Vol#: 572

CA 34133 M. K. Ehrich Vol#: 572

CA 34134 J. Norris Vol#: 572

CA 34135 Paul H. Phillips Vol#: 572

CA 34136 Ronald F. Costa Vol#: 572

CA 34139 Maryanne Phillips Vol#: 572

CA 34140 Dorothy C. Niblo Vol#: 572

CA 34141 Jean McDermott Vol#: 572

CA 34142 Nanette Pesel Vol#: 572

CA 34143 Don Dunkin Vol#: 572

CA 34144 Mrs. Elizabeth K. Myers Vol#: 572

CA 34145 Mr. & Mrs. Victor Gotay Vol#: 572

CA 34146 Mr. & Mrs. James Bishop Vol#: 572

CA 34147 Charlles H. Laughlin Vol#: 572

CA 34148 Mrs. Ray Herman Vol#: 572

CA 34149 Mrs. Ralph O. Bowden Vol#: 572

CA 34150 William A. Cotton Vol#: 572

CA 34151 James M. Irwin Vol#: 572

CA 34152 Gerry Kujawa Vol#: 572

CA 34153 Janice M. Forman Vol#: 572

CA 34154 Mary Hughes Vol#: 572

CA 34155 D. A. Wemble & Nancy C. Wemble Vol#: 572

CA 34156 Emma Hartzler Vol#: 572

CA 34157 Ms. Sharon Malick Vol#: 572

CA 34158 Mr. Eldon Jackson Vol#: 572

CA 34159 Mrs. Bernice A. Mosser Vol#: 572

CA 34160 Mrs. Donna Walker Vol#: 572

CA 34161 Joe B. Gilbert Jr. Vol#: 572

CA 34163 Ronald E. Stevens Vol#: 573

CA 34164 Mrs. Bernard M. Dreyfus, Jr. Vol#: 573

CA 34165 Mrs. Cathi Cole Vol#: 573

CA 34166 Joseph R. Neri Vol#: 573

CA 34167 Mrs. Davideen L. Rowland Vol#: 573

CA 34168 C. B. Halseth Vol#: 573

CA 34169 Herbert Novick Vol#: 573

CA 34170 Shirley & Derby Emerson Vol#: 573

CA 34171 C. B. Halseth Vol#: 571

CA 34172 Charles A. Braak, M. D. Vol#: 573

CA 34173 Lloyd Kester Vol#: 573

CA 34174 Mrs. Robert Van Poucke Vol#: 573

CA 34175 Phyllis & Jack Paterson Vol#: 573

CA 34176 T. E. Duffy Vol#: 573

CA 34177 Estelle J. Shives Vol#: 573

CA 34178 James C. Treat Vol#: 573

CA 34179 Noel & Christel A. Skippon Vol#: 573

CA 34180 Juanita Tucker Vol#: 573

CA 34181 D. M. Carter Vol#: 573

CA 34182 Kenneth G. Beimly Vol#: 573

CA 34183 Marguerite Irwin Vol#: 573

CA 34184 Sheilah R. Roberts Vol#: 573

CA 34185 W. M. O'Reilly Vol#: 573

CA 34186 Ronald S. Price Vol#: 573

CA 34187 James B. Ramage, C. L. U. Vol#: 573

CA 34188 Maria M. Marin & 6 other signatures Vol#: 573

CA 34189 The Jones Family Vol#: 573

CA 34190 Connie J. Reeds Vol#: 573

CA 34191 Albert E. Martin, P. E. Vol#: 573

CA 34192 Roland P. Vukic Vol#: 573

CA 34193 Micheal Rouse Vol#: 573

CA 34194 Diana & Edward Patterson Vol#: 573

CA 34195 Diana & Edward Patterson Vol#: 573

CA 34196 Everett Halvorsen Vol#: 573

CA 34197 Mr. & Mrs. John Schneider Vol#: 573

CA 34198 Mrs. M. J. Walters Vol#: 573

CA 34199 W. H. Coleman Vol#: 573

CA 34201 B. B. Finch Vol#: 573

CA 34202 John W. Trotter Vol#: 573

CA 34203 William G. Kretschmer Vol#: 573

CA 34204 Joseph J. Smith Vol#: 573

CA 34205 Jane Trotter Vol#: 573

CA 34207 J. M. Smith Vol#: 573

CA 34208 H. L. Williams Vol#: 573

CA 34209 Harden Young Vol#: 573

CA 34210 Frank A. Brown Vol#: 573

CA 34211 Dennis L. Davis Vol#: 573

CA 34212 J. E. Looney Vol#: 573

CA 34213 Jerome Glassman Vol#: 573

CA 34214 Burton H. Patterson Vol#: 573

CA 34215 Kathie Wyant Vol#: 573

CA 34216 Aibarton Krause Vol#: 573

CA 34217 Kenneth R. Briggs, M. D. Vol#: 573

CA 34218 Dyson W. & Janice L. Cox Vol#: 573

CA 34219 Bernard Grafton Vol#: 573

CA 34220 Eugene H. Slovak Vol#: 573

CA 34221 Miss. Elendon McVaigh Vol#: 573

CA 34222 Patricia A. Jackson Vol#: 573

CA 34224 Dana P. Childs Vol#: 573

CA 34225 Russell D. Gist Vol#: 573

CA 34226 Ruth M. Rosekilde Vol#: 573

CA 34227 Mrs. Margaret P. Collins Vol#: 573

CA 34228 Hazel Evey Vol#: 573

CA 34229 Mr. Patrick F. Spence Vol#: 573

CA 34230 James E. Mollus Vol#: 573

CA 34231 Donald Stone Vol#: 573

CA 34232 Mrs. Jean L. Gordon Vol#: 573

CA 34234 Ruby A. Love Vol#: 573

CA 34235 Anne Wybierala Vol#: 573

CA 34236 Carl Cohen Vol#: 573

CA 34237 Evelyn J. Boyd Vol#: 573

CA 34238 Robert G. Nix Vol#: 573

CA 34239 Mrs. Margaret Erb Vol#: 573

CA 34240 Susannah Acker Vol#: 573

CA 34241 Mrs. Henry Kuhl Vol#: 573

CA 34242 Mrs. Helen T. Krivonak Vol#: 573

CA 34243 Reily G. Adams Vol#: 573

CA 34244 June W. Brown Vol#: 573

CA 34245 Miss. Barbara A. Rodrock Vol#: 573

CA 34246 Debra J. O'Bryan Vol#: 573

CA 34247 Julienne Wallace Vol#: 573

CA 34249 John E. Button Vol#: 573

CA 34250 W. Paul Settles Vol#: 573

CA 34251 Micheal & Mark Dervay Vol#: 573

CA 34252 Mrs. William Hughes Vol#: 573

CA 34253 Winifred Dye Vol#: 573

CA 34254 Mrs. Margaret W. Kriete Vol#: 573

CA 34255 Verna A. Hausen Vol#: 573

CA 34256 Mrs. Jeron R. Fitzmorris Vol#: 573

CA 34257 Mrs. Bill Muney Vol#: 573

CA 34258 Rebecca Hillman Vol#: 573

CA 34259 Number Not Used Vol#: 573

CA 34260 E. D. Harmer Vol#: 573

CA 34261 Kim Hull Vol#: 573

CA 34262 Louis S. Boffo Vol#: 573

CA 34263 Calvin E. Hendricks Vol#: 574

CA 34264 Mrs. Pearl Domaschofsky Vol#: 574

CA 34265 Dorothy Del Monte Vol#: 574

CA 34266 Mrs. Clara Culpepper Vol#: 574

CA 34267 Esther & N. E. Micheals Vol#: 574

CA 34268 C. R. Rader Vol#: 574

CA 34269 Mrs. L. Rudrepl Vol#: 574

CA 34270 Constance M. & Joseph A. DeSimone Vol#: 574

CA 34271 Agnes M. Stalker Vol#: 574

CA 34272 Jean Riley Vol#: 574

CA 34273 Rose Blake Vol#: 574

CA 34274 Mrs. George W. Householder, Jr. Vol#: 574

CA 34275 Esther & Marvin Kovel Vol#: 574

CA 34276 Vera Mosher Vol#: 574

CA 34277 Dennis L. Dunlap Vol#: 574

CA 34278 Marlene J. Aevo Vol#: 574

CA 34279 Nadine E. Risley Vol#: 574

CA 34280 David R. Drobis Vol#: 574

CA 34281 Mary Ellen Ask Vol#: 574

CA 34282 Mel Guthman Vol#: 574

CA 34283 Margaret J. Massalsky Vol#: 574

CA 34284 Diana P. Fish & 6 other signatures Vol#: 574

CA 34285 June Celeste Sugar Vol#: 574

CA 34286 Nick Pappas Vol#: 574

CA 34287 Kay R. Maltbie Vol#: 574

CA 34288 Barbara Jacobi Vol#: 574

CA 34290 Mrs. E. S. Otto Vol#: 574

CA 34291 Joe W. Gill Vol#: 574

CA 34292 Mrs. George A. Grabski Vol#: 574

CA 34293 Joseph P. Tobin Vol#: 574

CA 34294 Mrs. May Smith Vol#: 574

CA 34295 Dolores Graff Vol#: 574

CA 34297 Frank Senior Vol#: 574

CA 34298 Ron McMahan Vol#: 574

CA 34299 Micheal A. Augustine Vol#: 574

CA 34300 Jack Matlack Vol#: 574

CA 34301 Mrs. Shirley Weger Vol#: 574

CA 34302 Wilbur Schultz Vol#: 574

CA 34303 Anna May Corbett Vol#: 574

CA 34304 Mr. & Mrs. Walter Finley Vol#: 574

CA 34305 Number Not Used Vol#: 574

CA 34306 June V. Howard, R. N. Vol#: 574

CA 34307 Jacqueline Rowles Vol#: 574

CA 34308 Isabelle Brous Vol#: 574

94S-0120 510K Substantially Equivalent List

LST 109 List of December 2001 Vol#: 25

LST 110 Cumulative 510K, January - December 2001 Vol#: 26

95P-0273 Waiver for Feminine Gold external topical analgesic lotion

PDN 1 HFD-560 to Au Pharmaceuticals Inc. Vol#: 1

97E-0465 Patent Extension; Bayer Corporation / Baycol

LET 3 HFD-005 to US Patent & Trademark Office Vol#: 1

98E-0476 Infergen(interferon alfacon-1)U.S.Patent Ext #4,695,623

LET 4 HFD-5 to U S Patent & Trademark Office Vol#: 1

98E-0838 Patent Extension DETROL (tolterodine tartrate) 5,382,600

LET 4 HFD-5 to U S Patent & Trademark Office Vol#: 1

98V-1233 Variance for protocols & software reporting requirements

VRA 2 HFZ-300 to William A Gibson Vol#: 1

99E-0117 Patent Extension Heart Laser, # 5,125,926

NEC 1 Vol#: 1

99E-1071 Provigil, Patent No. 4,177,290

LET 3 HFD-5 to US Patent & Trademark Office Vol#: 1

99P-1340 Declared Eternity eau de Parfum Misbranded

EMC 352 Linda Squires Vol#: 18

EMC 353 Eva Manditch Vol#: 18

EMC 354 Graham Guthrie Vol#: 18

EMC 355 Agnes Malouf Vol#: 18

EMC 356 Ruth Walker Vol#: 18

99P-4613 Revoke the Regulation That Approved Posilac

EMC 2409 John E. Dunlop Vol#: 44

EMC 2410 Lauri Rowell Vol#: 44

EMC 2411 Roger B.G. Harmone Vol#: 44

EMC 2412 No signature Vol#: 44

99P-5106 Identify Sources of Natural Flavorings

EMC 134 Robert Archangel Vol#: 2

99P-5198 Request amendment of the definition of milk

C 6 National Chesse Institute Vol#: 1

00D-1538 Electronic Records; Electronic Signatures, Validation

C 25 Wyeth-Ayerst Research Vol#: 6

EMC 4 Fort Dodge Animal Health Vol#: 6

LST 9 Gen. References for Guidance 01/28/02 Vol#: 6

00D-1539 Electronic Records & Signatures, Retention of Electronic Rec

LST 9 Gen. References for Guidance 01/28/02 Vol#: 5

00D-1540 Electronic Signatures, Electronic Copies of Electronic Recor

LST 9 Gen. References for Guidance 01/28/02 Vol#: 5

00D-1541 Electronic Signatures: Audit Trails

LST 9 Gen. References for Guidance 01/28/02 Vol#: 5

00D-1542 Electronic Signatures: Time Stamps

LST 9 Gen. References for Guidance 01/28/02 Vol#: 5

00D-1543 Electronic Signatures: Glossary of Terms

C 19 Wyeth-Ayerst Research Vol#: 7

LST 9 Gen. References for Guidance 01/28/02 Vol#: 7

00E-1254 Patent Extension Gabitril #5,010,090

LET 3 HFD-5 to U S Patent & Trademark Office Vol#: 1

00E-1412 Patent Extension UVASORB HA88, No. 4,477,615

LET 2 HFD-5 to US Patent & Tradmark Office Vol#: 1

00E-1413 Patent Extension Xenical (orlistat), No. 4,598,089

LET 2 HFD-5 to US Patent & Trademark Office Vol#: 1

00N-1396 Bioengineered Foods Consumed By Humans or Animals

C 9216 Daniel Sackett Vol#: 401

EMC 11533 Keith & Deanna Ronningen Vol#: 349

EMC 11534 Susan Morvin Dinkins Vol#: 349

EMC 11535 Susan Morvin Dinkins Vol#: 349

EMC 11536 Frances Minneci Vol#: 349

00P-0586 Amend Pt 133.3 re:Milk and Nonfat Milk for use in Standardiz

C 31 National Cheese Institute Vol#: 2

01D-0488 Food-Effect Bioavailability & Fed Bioequivalence Studies

C 2 AstraZeneca, LP Vol#: 1

C 3 Procter & Gamble Company Vol#: 1

C 4 Pharmacia Vol#: 1

C 5 Mylan Pharmaceuticals, Inc. Vol#: 1

C 6 MDS Pharma Services Vol#: 1

C 7 Bristol-Myers Squibb Vol#: 1

C 8 Eon Laboratories, Inc. Vol#: 1

C 9 Merck, Co., Inc. Vol#: 1

01D-0501 Management of Periodic Summary Update Reports

C 1 American Veterinary Medical Assn Vol#: 1

01D-0583 Food Security Guidance

EMC 2 K. Brau, Jr. Vol#: 1

EMC 3 Margaret Gryko Vol#: 1

01F-0047 Foodborne pathogens in raw-frozen-cooked-partially cooked

EMC 146 Matthew Thompson Vol#: 3

EMC 147 Kristine Acevedo Vol#: 3

EMC 148 Beth Helm Vol#: 3

EMC 149 Cynthia Milutin Vol#: 3

EMC 150 Sheryl Loucks Vol#: 3

EMC 151 Janet Hitt Vol#: 3

EMC 152 Zachery Rodgers Vol#: 3

01N-0589 Extralabel Drug Use in Animals

N 1 Vol#: 1

01N-0590 Salmonella Discovery System Pilot Study

N 1 Vol#: 1

01P-0585 Requirement of ANDA for Mixed Salts of Single Entity Amphet

LET 1 HFD-7 to Arnall Golden Gregory, LLP Vol#: 1

01P-0586 New and/or Amended Regulations for BPCA

PDN 1 HFC-1 to Bristol-Myers Squibb Company Vol#: 1

02V-0048 Laser Light Show

ACK 1 HFA-305 Vol#: 1

VAR 1 Musique Express Vol#: 1